Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening in the Community
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,556
- 试验地点
- 2
- 主要终点
- Number of participants who complete screening
研究概览
简要总结
This study examines prevention and early detection of cervical cancer through self-administration screening of patients in Western Uganda. The cervix is the opening of the uterus or womb, which is the organ that supports babies before they are born. There are simple tests that let doctors know whether or not patients have cells that may become cancer. Some of the tests determine whether patients have an increased risk for cervical disease, but they do not actually confirm that they have it: these are called "screening" tests. This study may help researchers determine how to best deliver cervical cancer prevention services using the HPV test.
详细描述
PRIMARY OBJECTIVES:
I. To establish the acceptance and correlates of self-collected human papillomavirus (HPV)-ribonucleic acid (RNA) testing among women in the rural Ugandan community as well as the incidence and determinants of successful completion of the cervical cancer screening cascade from self-collected HPV testing to receipt of results.
II. To ascertain the frequency and determinants of successful acquisition of treatment among women who have HPV detected on self-collected swabs in rural Uganda.
III. To derive population-based estimates of the prevalence of high-risk HPV and cervical intraepithelial neoplasia (CIN) detected through community-based screening employing self-collected HPV RNA testing in rural Uganda.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in the three Ugandan districts (Kiboga, Kyankwanzi and Hoima) who access screening during the community health campaigns
- •Age 25-49 years
- •Resident in the study district
- •Provision of informed consent
排除标准
- •Clinical signs and symptoms of cancer of the cervix
研究组 & 干预措施
Screening
Patients receive a specimen kit for collection of HPV samples. Patients complete questionnaire before and after collection HPV samples. Patients may also participate in an interview about general ideas in improving the screening and treatment process. Patients with positive results, undergo treatment for cervical cancer.
干预措施: HPV testing (Diagnostic Test)
Screening
Patients receive a specimen kit for collection of HPV samples. Patients complete questionnaire before and after collection HPV samples. Patients may also participate in an interview about general ideas in improving the screening and treatment process. Patients with positive results, undergo treatment for cervical cancer.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Number of participants who complete screening
时间窗: 1 day
The absolute number of participants successfully completing screening.
Proportion of participants with positive, high-risk human papillomavirus (HPV)
时间窗: 1 day
Prevalence of participants with positive high-risk human papillomavirus (HPV)
Proportion of women 25-49 years of age who complete screening
时间窗: 1 day
Overall proportions of women 25-49 years old successfully completing cervical cancer screening.
Proportion of participants who receive treatment after a positive screening result
时间窗: 6 months
Proportion of participants who receive treatment after screening positive for high-risk human papillomavirus (HPV) will be calculated with a 95% confidence interval.
Proportion of participants with cervical intraepithelial neoplasia (CIN2)+
时间窗: 1 day
Proportion of participants with cervical intraepithelial neoplasia (CIN2)+
次要结局
未报告次要终点